Intradermal needle-less injection device

ABSTRACT

A programmable injection device, comprising: a nozzle comprising a nozzle head with a fluid input hole and a distinct injection hole, the nozzle head accepts a dose of fluid from the fluid input hole to be injected into the skin of a patient through the injection hole, without use of a needle, a fluid capsule that is connected to said nozzle head and is adapted to provide the nozzle head with multiple doses of fluid for successive injections, without replacing the fluid capsule, an injection head that is adapted to have said fluid capsule and said nozzle head mounted onto it, comprising a first mechanism adapted to forcefully push a dose of a programmable amount of fluid from said fluid capsule to said nozzle head and a second mechanism for injecting by an programmable pressure said dose of fluid from said nozzle head into the skin of a patient in at least one of a programmable velocity or a programmable pressure applied to the skin surface.

RELATED APPLICATIONS

The current application is a divisional application of U.S. applicationSer. No. 12/306,690 filed Dec. 25, 2008, now U.S. Pat. No. 7,824,360which claims priority from U.S. provisional applications No. 60/816,866filed on Jun. 28, 2006 and application No. 60/907,564 filed on Apr. 9,2007, the disclosures of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to needle-less injection offluids subcutaneously or intradermally, and specifically to methods anddevices for performing such.

BACKGROUND OF THE INVENTION

In many medical and cosmetic procedures there is a need to transferfluids to areas below the surface of the skin, for example injectinginsulin to diabetics and filling the dermal layer of the skin withcollagens or other materials to preserve a youthful look. The mostcommon method for introducing the fluids is by using a needle to injectthe fluid to the desired position. The use of needles to administer thefluids requires that the administrator be trained to perform theprocedure correctly so as not to cause damage. In many cases the exactposition of injection is important to achieve the correct results.Generally, the use of needles causes damage to the skin and asignificant amount of time is required for the damage to heal.

In recent years the injection of fluids using needle-less injectors hasadvanced. When using needle-less injectors, less training is requiredfor a person to administer the injection, thus for example massvaccination campaigns can be performed using untrained staff.Additionally, when using needle-less injections the penetration hole isgenerally smaller thus enabling the administration of more injectionswhile minimizing damage to the surface of the skin. Additionally, newerskin augmentation methods rely on the self healing process of the skin,wherein the skin rejuvenates itself. In rejuvenation layers arethickened, and more collagen fibers are introduced. When using a needledamage is incurred to the skin surface but little trauma is caused tothe cells of the internal layers of the skin, thus little rejuvenationis achieved.

A device that injects fluid subcutaneously or intradermally needs to beable to create a high pressurized jet of fluid with a small diameter sothat it will be able to penetrate the epidermis layer of the skin.Generally, the device is more complicated than the common syringe forinjecting fluids with a needle. Thus the needle-less injector tends tobe heavier, more expensive and harder to control than the common needleinjector.

Additionally, due to its simplicity and low cost the common needleinjector is generally intended for a single use, thus preventingcontamination and the spread of disease. In contrast the more complexneedle-less device is mostly non-disposable and needs requiressterilization or additional precautions to prevent the transfer ofcontamination from one patient to another.

SUMMARY OF THE INVENTION

An aspect of an embodiment of the invention, relates to a needle-lessinjection device for injecting a fluid into the skin of a patient. Thedevice includes a capsule for providing the fluid to the device. Thecapsule provides one or more doses of the fluid for injection into theskin of a patient. A nozzle is connected to the capsule (e.g. directlyor with a tube) to receive a dose of fluid for injecting. The deviceincludes an injection head to accommodate the capsule and the nozzle,wherein the injection head has a first mechanism to push a dose from thecapsule into the nozzle head, and a second mechanism to inject a highpressure jet stream of the fluid into the skin of the patient.Optionally, a third mechanism is used to coordinate between the twomechanisms so that they will interact together. In an exemplaryembodiment of the invention, the third mechanism positions the secondmechanism according to the actions that need to be taken by the device.When a dose of fluid is loaded in the nozzle by the first mechanism thethird mechanism places the second mechanism in a first position. Whenthe fluid is loaded in the nozzle and ready for injection, the thirdmechanism places the second mechanism in position to inject the fluid.After injecting the fluid the third mechanism releases the secondmechanism so that the process may be repeated.

In an exemplary embodiment of the invention, all of the mechanisms areactivated by compressed gas. Optionally, a single source of compressedgas activates all mechanisms. In some embodiments of the invention, themechanisms are activated by other methods, such as a spring or anelectrical motor. In some embodiments of the invention, one mechanism isactivated by one method and the other mechanisms are activated by adifferent method.

In some embodiments of the invention, the device includes a base forsupporting the injection head so that a person does not need to supportthe weight of the device. Optionally, a beam is connected to andpositioned above the device to support the injection head. In anexemplary embodiment of the invention, the beam is weighted at differentpoints so that the injected head will be balanced by the beam.Alternatively, the beam is weighted so that the beam will lift theinjection head when not being held by the user.

In an exemplary embodiment of the invention, the capsule provides anumber of doses for treating a patient and can be replaced with a newcapsule when its content is finished. Optionally, the nozzle and theconnection between the nozzle and the capsule are also disposable.Optionally, the nozzle is replaced for each patient, since it might bein contact with the patient's skin and might be in contact with bloodfrom the patient.

In some embodiments of the invention, a nozzle base is provided tointerface between the nozzle and the patients skin so that a specificdistance will be maintained when injecting fluid into the patients skin.Optionally, the nozzle base is adapted to confine a specific shaped areaduring injection so that the injected fluid will disperse mainlythroughout the confined area. In an exemplary embodiment of theinvention, a larger skin area is injected like in a tiling process byinjecting an area and then injecting the neighbor areas to cover thelarger area without overlapping.

There is thus provided according to an exemplary embodiment of theinvention, a needle-less fluid injection device, comprising:

a nozzle head with an injection hole for accepting a dose of fluid to beinjected into the skin of a patient;

a fluid capsule that is connected to the nozzle head and provides thenozzle head with one or more doses of fluid for injection;

an injection head for mounting the fluid capsule and the nozzle headcomprising a first mechanism for releasing a dose of fluid from thefluid capsule to the nozzle and a second mechanism for injecting thedose of fluid from the nozzle into the skin of a patient. Optionally thedevice further comprises a third mechanism to coordinate between thefirst and second mechanism; wherein the third mechanism is adapted tocontrol the positioning of the second mechanism.

In an exemplary embodiment of the invention, the device furthercomprises, a base for supporting the injection head, and a beam coupledto the base. Optionally, one or more weights are positioned on the beamso that the injection head is balanced by the beam above the base.Alternatively, one or more weights are positioned on said beam so thatsaid injection head is lifted upward in equilibrium. In an exemplaryembodiment of the invention, the device further comprises a compressor.Optionally, the device further comprises a gas balloon to storecompressed gas. In an exemplary embodiment of the invention, the devicefurther comprises a pressure control valve to regulate the pressureprovided to the injection head. Optionally, the fluid capsule isdisposable. In an exemplary embodiment of the invention, the nozzle isdisposable. In an exemplary embodiment of the invention, the devicefurther comprises a disposable tube to connect between the fluid capsuleand the nozzle. Optionally, the second mechanism injects the fluid withan initial pressure of between 100 to 150 Atmospheres.

In an exemplary embodiment of the invention, the first mechanism isactivated by a compressed gas. Alternatively, the first mechanism isactivated by an electric, magnetic or electromagnetic force. Furtheralternatively, the first mechanism is activated by a spring. In anexemplary embodiment of the invention, the second mechanism is activatedby a compressed gas. Alternatively, the second mechanism is activated byan electric, magnetic or electromagnetic force. Further alternatively,the second mechanism is activated by a spring. In an exemplaryembodiment of the invention, the injection hole of the nozzle has adiameter of less than 0.5 mm. Optionally, the diameter of the injectionhole of said nozzle is between 0.1 to 0.3 mm. In an exemplary embodimentof the invention, the nozzle has multiple injection holes. Optionally,the nozzle has an additional hole on the side to release air from thefluid before injecting the fluid. In an exemplary embodiment of theinvention, the device is programmable. Optionally, the velocity of theinjected fluid is programmable. In an exemplary embodiment of theinvention, the depth of penetration is programmable. Optionally, theamount of fluid released in a single injection is programmable. In anexemplary embodiment of the invention, the pressure applied to the fluidis programmable. In an exemplary embodiment of the invention, the devicefurther comprises a nozzle base for the nozzle head which positions theinjection hole at a predetermined distance from the skin of the patient.Optionally, each side of the nozzle base is adapted to position thenozzle head at a different distance from the skin of the patient and thedistance is selectable by rotation of the nozzle head. In an exemplaryembodiment of the invention, the distance is between 1 to 20 mm.Optionally, the nozzle base is transparent and marked on the sides witha view finder to assist in positioning the nozzle base. In an exemplaryembodiment of the invention, the nozzle base is adapted to confine aspecific shaped area of skin during injection.

There is thus further provided according to an exemplary embodiment ofthe invention, a method of injecting fluid into skin, comprising:

pushing a single dose of fluid from a disposable capsule to an injectionnozzle, using a first mechanism;

positioning a second mechanism to allow the dose of fluid to enter theinjection nozzle;

moving the second mechanism to extract air from the nozzle and be readyto inject the fluid;

injecting the fluid in the nozzle by exerting a high pressure on thefluid with the second mechanism;

releasing the second mechanism to allow injection of another dose offluid;

wherein coordination between the first mechanism and the position of thesecond mechanism is controlled by a third mechanism; and

wherein all three mechanisms are encased in a single encasement.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and better appreciated from thefollowing detailed description taken in conjunction with the drawings.Identical structures, elements or parts, which appear in more than onefigure, are generally labeled with the same or similar number in all thefigures in which they appear, wherein:

FIG. 1 is a perspective view of a needle-less injection device,according to an exemplary embodiment of the invention;

FIG. 2A is a cross sectional view of an injection unit from aneedle-less injection device, according to an exemplary embodiment ofthe invention;

FIG. 2B is an exploded view of an injection unit from a needle-lessinjection device, according to an exemplary embodiment of the invention;

FIG. 3A is an exploded view of an injection nozzle, according to anexemplary embodiment of the invention;

FIG. 3B is a schematic illustration of an injection nozzle in a deployedposition, according to an exemplary embodiment of the invention; and

FIG. 4 is a flow diagram of a method of using a needle-less injectiondevice, according to an exemplary embodiment of the invention.

DETAILED DESCRIPTION

FIG. 1 is a perspective view of a needle-less injection device 100,according to an exemplary embodiment of the invention. In an exemplaryembodiment of the invention, device 100 comprises an injection unit 200for injecting fluids into the skin of a person or an animal. Injectionunit 200 includes a mechanism for forming a highly pressurized jetstream of the fluid to penetrate the subject's skin. In some embodimentsof the invention, the weight of injection unit 200 is greater than 100gr, for example between 300 gr to 2 Kg and would be cumbersome for aperson to hold and accurately aim at a patient without support. In anexemplary embodiment of the invention, injection unit 200 is supportedby device 100, which comprises a crane system made up from a console110, a vertical axis 145, a beam 120, a counter weight 125 and an pivot135. Optionally, device 100 supports injection unit 200 in a balancedstate so that the user only needs to provide a minimal force to positioninjection unit 200 and to hold it steady in contact with the patient.Alternatively, counter weight 125 is slightly heavier so that injectionunit 200 will rise up and distance itself from the patient when not heldby the user of device 100.

In an exemplary embodiment of the invention, the crane system allowsinjection unit 200 to be moved with little effort. Optionally, springsor hydraulic joints are used to control the motion of device 100 inmultiple directions, so that injection unit 200 can be positioned forinjection in the direction selected by the user with little effort.

In some embodiments of the invention, device 100 utilizes pressurizedair or other gases to inject the fluid from injection unit 200, forexample as shown in FIG. 1. Alternatively or additionally, the mechanismfor injecting the fluid of injection unit 200 may be based on othermechanisms, for example a spring mechanism, which is loaded by the userand produces the highly pressurized jet stream of fluid when released.Another exemplary mechanism uses electromagnetic means (e.g. anelectromagnetic motor) to push the fluid out of injection unit 200 at ahigh speed.

In an exemplary embodiment of the invention, console 110 includes adisplay 140 and input means 170, for example a touch screen, selectionbuttons or a keypad to communicate with the user and accept commandsregarding the control of injection unit 200. Optionally, the user maydefine parameters such as:

1. Velocity of the jet injection;

2. Depth of penetration;

3. Amount of fluid released;

4. Pressure applied to the skin surface;

5. Pressure applied to the injected fluid;

6. Temperature of the injected fluid;

7. Time interval for application of the pressure;

8. Impulse shape.

Some of the above parameters may require the addition of extra parts todevice 100, which are not provided in all embodiments of the invention,for example to control the temperature of the injected fluid injectionunit 200 may require a temperature sensor and a heating or coolingelement.

In an exemplary embodiment of the invention, console 110 serves as aweight to stabilize device 100. Optionally, console 110 additionallyincludes a closet 115 to accommodate a power supply 175, a gas balloon155, a compressor 160 for compressing air and storing it in gas balloon155, and a pressure control valve 165 to control the pressure providedby console 110. In an exemplary embodiment of the invention, device 100includes cables 185 from console 110 to injection unit 200 (via verticalaxis 145, beam 120 and pivot 135) to transfer the pressurized gas and/orelectricity for controlling the device. Optionally, console 110 includesa base 150 with wheels 180 to allow device 100 to be readily moved nearthe patient. In some embodiments of the invention, base 150 includesweights or is made from a heavy material, for example lead or otherheavy metals, to provide stability. In some embodiments of theinvention, device 100 may weigh between 50 to 250 Kg although in somecases it may weigh more or less. Optionally, the height of device 100 isdesigned according to the height of a person, for example between 1.5meters to 2 meters, so that it is readily applied to a sitting orstanding person.

FIG. 2A is a cross sectional view of injection unit 200 from needle-lessinjection device 100, according to an exemplary embodiment of theinvention, and FIG. 2B is an exploded view of injection unit 200 fromneedle-less injection device 100, according to an exemplary embodimentof the invention. In an exemplary embodiment of the invention, injectionunit 200 is designed to accept a fluid capsule 260, which is providedwith a quantity that is sufficient to provide a multiple number ofinjections, for example 50 injection doses or 100 injection doses.Optionally, a tube 270 is connected between fluid capsule 260 and anozzle head 320 of a nozzle 300 to allow the transfer of a single doseof fluid for injection. In an exemplary embodiment of the invention,injection unit 200 comprises 3 mechanisms to be able to inject fluidinto a patient. Optionally, a first mechanism 210 pushes a plunger thatprovides a single dose of fluid from fluid capsule 260 to nozzle 300. Inan exemplary embodiment of the invention, a second mechanism 220provides a high pressure force that injects the fluid from nozzle 300into the patient. Optionally, a third mechanism 215 coordinates betweenthe first mechanism and the second mechanism. In an exemplary embodimentof the invention, mechanism 215 positions mechanism 220 according to thestage of mechanism 210. Optionally, mechanism 215 positions mechanism220 so that nozzle 300 is open to accept the fluid provided usingmechanism 210. Then mechanism 215 positions mechanism 220 to be ready toinject the fluid. After injecting the fluid mechanism 215 releasesmechanism 220 to accept another dose of fluid for injection

In some embodiments of the invention, injection unit 200 only uses thefirst mechanism 210 and second mechanism 220, wherein the user positionsthe mechanisms so that the actions performed will be coordinated.

In some embodiments of the invention, a pressure control system 230controls the provision of air pressure from gas balloon 155 to activatethe three mechanisms (210, 215, 220). In an exemplary embodiment of theinvention the above listed parts of injection unit 200 are placed in anencasement that comprises right panel 240, left panel 245 and fluidcapsule protector 250. Optionally, injection unit 200 is attached topivot 135 via pivot socket 280 so that it can be rotated by 180° or even360° for positioning on a patient.

In an exemplary embodiment of the invention, fluid capsule 260 is sealedwith a seal 265 (e.g. a rubber or plastic cork) to keep the fluidsterile. Optionally, seal 265 is placed internal to fluid capsule 260,so that it may be pushed inward by mechanism 210 to force the fluid fromfluid capsule 260 into nozzle 300, without contaminating the fluid. Inan exemplary embodiment of the invention, nozzle 300 is also sealed witha plunger 330 that is controlled by mechanism 220 to be raised andlowered in nozzle head 320, so that the fluid is injected withoutcontact with injection unit 200. Optionally, the parts of injection unit200 that provide the fluid and come in contact with the patient are allindependent and disposable to prevent contamination and infection.Specifically, fluid capsule 260, tube 270, nozzle 300 and their subpartsas listed above, are all disposable. In an exemplary embodiment of theinvention, a new sterile fluid capsule 260, tube 270 and nozzle 300 areprovided for injecting multiple doses of fluid for each patient. As anexample in many cosmetic treatments a skin area is treated by performingmultiple injections one after another while advancing incrementallyacross the skin to cover the entire area.

In some embodiments of the invention, capsule 260 and tube 270 may beprovided for injection to multiple patients. Optionally, nozzle 300 isreplaced for each patient and fluid capsule 260 is replaced when it isempty, for example when vaccinating a large number of people.

FIG. 3A is an exploded view of injection nozzle 300, according to anexemplary embodiment of the invention, and FIG. 3B is a schematicillustration of injection nozzle 300 in a deployed position, accordingto an exemplary embodiment of the invention.

Optionally, as described above, nozzle 300 includes three separateparts, nozzle base 310, nozzle head 320 and a plunger 330. Nozzle head320 is attached to injection unit 200 with nozzle interface 340, andplunger 330 is grasped by mechanism 220, so that it can be moved up anddown in nozzle head 320. In an exemplary embodiment of the invention,nozzle head 320 comprises an entrance 350, which is attached to one endof tube 270 and receives a dose of the fluid for injection from fluidcapsule 260. Optionally, the fluid fills up the lower part of nozzlehead 320 according to the designated dosage (e.g. up to line 345 that isbelow entrance 350). Optionally, a pressure hole 355 is positioned on aside of nozzle head 320 above line 345 to allow air to exit whenpositioning plunger 330 and mechanism 220 in position for injecting thefluid from nozzle head 320.

In an exemplary embodiment of the invention, the fluid is ejected fromnozzle head 320 via a small hole 325. Optionally, hole 325 is largeenough to allow a jet stream of the fluid to be ejected through hole325, but small enough (e.g. less than 0.5 mm) to prevent the fluid fromdripping out when no pressure is exerted as a result of the viscosity ofthe fluid. Optionally, the size used for hole 325 depends on the type offluid injected, for example for water a diameter between 0.1 mm and 0.3mm is sufficient. In some embodiments of the invention, nozzle head 320has multiple holes 325 to form multiple jet streams when injecting thefluid.

In some embodiments of the invention, nozzle base 310 may be providedwith any shaped opening facing downward to be deployed on the patientsskin and causing nozzle head 320 to be positioned at a preset distancefrom the patient's skin (e.g. between 1 mm to 20 mm). Optionally, whenreleasing mechanism 220 nozzle base 310 confines a patch of skin andpushes against the skin causing the confined area to rise toward nozzlehead 320. As a result the injected stream disperses more evenly in thedermis below the confined area.

In an exemplary embodiment of the invention, the internal diameter ofnozzle base 310 approximately matches the external diameter of nozzlehead 320 so that nozzle head 320 will be held firmly by nozzle base 310.Optionally, the downward opening of nozzle base 310 may be rectangularor square to simplify the process of injecting fluid to a larger area ofthe patient's skin without overlap. Optionally, a user would inject thefluid to one position and advance incrementally over the skin untilcovering the entire larger area with or without overlap. In an exemplaryembodiment of the invention, nozzle base 310 has a different height ondifferent sides of its circumference, for example as illustrated in FIG.3A side 314 is highest then side 313 then side 312 and then side 311.Optionally, nozzle head 320 comprises a rest protrusion 335, which ispositioned to rest on one of the sides (311, 312, 313, and 314) ofnozzle base 310 to prevent it from descending deeper into base 310 andgetting closer to the skin of the patient. Thus by selecting a side forrest protrusion 335 the user determines the distance between hole 325and the patient's skin, for example the distance may be set to bebetween 1 mm to 20 mm or more or less. Optionally, the distance betweenhole 325 and the patient's skin affects the form of the injection streamthat penetrates the patient's skin.

FIG. 4 is a flow diagram 400 of a method of using needle-less injectiondevice 100, according to an exemplary embodiment of the invention. In anexemplary embodiment of the invention, a user programs device 100setting (410) parameters for performing fluid injection, for examplesetting the pressure value that will be applied to inject the liquid orthe size of the dose that will be injected each time. The user thenloads (420) a fluid capsule 260 with the fluid that is to be injected.It should be noted that the fluid may be a gas, a liquid, a cream or apowder that was dissolved in liquid.

In an exemplary embodiment of the invention, the external layer of theskin is treated (430) prior to injecting the fluid, for example byapplying lotions or moister (e.g. alcohol) to the injection area on theepidermis layer 360 of the patient's skin (shown in FIG. 3B) or bycooling or warming the area. Optionally, treatment of the skin canreduce resistance, reduce sensation or prevent contamination. In someembodiments of the invention, the patient's skin is treated for anextended amount of time (e.g. 40-60 minutes) prior to injection so thatthe injection process will be more effective.

After optionally treating the skin, injection unit 200 is positioned(440) over the area that needs to be injected. Nozzle base 310 ispressed against epidermis layer 360 causing the dermis layer 365 that isconfined by nozzle base 310 to rise up toward nozzle head 320. In anexemplary embodiment of the invention the user of device 100 instructsinjection head 200 to load (450) a dose of fluid into nozzle head 320,then injection head 200 releases mechanism 220 to apply pressure on thefluid in nozzle head 200 and inject it (460) in the form of a jet streamtoward the patient's epidermis. In an exemplary embodiment of theinvention, the jet stream is injected at a pressure between 100Atmospheres to 200 Atmospheres, for example 120 Atmospheres or 150Atmospheres, so that it will penetrate epidermis 360 and disperse indermis 365. Optionally, control of the injection pressure determines thedepth in the skin into which the injected fluid will reach.

It should be noted that the above process may be performed in adifferent order, for example treating the skin (430), loading thecapsule (420), setting parameters (410), loading a dose (450),positioning the device (440) and then injecting (460) the fluid.

In some embodiments of the invention, nozzle base 310 is transparent andmarked on the sides with a view finder 315 to assist in positioningnozzle base 310 on the patient's skin, for example the view finder maybe marked at the median between the corners.

In some embodiments of the invention, injection unit 200 includes asensor 285, which tests the quality of the skin being injected, forexample using an ultrasound wave or a light. Optionally, parameters ofdevice 100 are set automatically, according to the determined skinquality, for example using a higher injection pressure for hard skin anda lower injection pressure for soft skin.

In an exemplary embodiment of the invention, device 100 is used toinject a dermal filler fluid into aged skin to improve the cosmetic lookof the skin. In the aging process the connections between the cells inthe dermal layer are weakened causing the skin to become lax, wrinkledand dry. Optionally, by injecting a dermal filler material in a highspeed stream the filler material penetrates epidermis 360 and dispersesin dermis 365. When dispersing in dermis 365 the particles of the highspeed stream traumatize the dermal cells initiating a healing process,which causes the dermal cells to be rejuvenated. The rejuvenationreturns the youthful look and feel of the skin for an extended period(e.g. a few years). Immediately after injection, the dermal fillermaterial provides the youthful look. Over time the dermal fillerdecomposes (e.g. within 1-3 months). At the same time the rejuvenationprocess begins to show so that in the long run the skin retains itsyouthful look. In an exemplary embodiment of the invention, the successof the cosmetic process is enhanced by using device 100. Optionally, byconfining an area of the skin with nozzle base 310, when injecting thehigh speed stream of filler material, the filler material dispersesbetter in the confined area. Thus by covering a larger skin area pieceby piece a larger skin area can be covered more effectively.

In an exemplary embodiment of the invention, dermal filler fluids mayinclude: collagen, hyaluronic acid, fat, silicon, water,Polymethylmethacrylate Microspheres (PMMA), Calcium Hydroxy ApatiteMicrospheres (CaHA), Polyvinyl Alcohol (PVA), Polyethylene Glycol (PEG)and the like. Optionally, the dermal filler material may be heated (e.g.to between 40° C.-70° C.) prior to injection, to enhance dispersion inthe dermal layer.

It should be appreciated that the above described methods and apparatusmay be varied in many ways, including omitting or adding steps, changingthe order of steps and the type of devices used. It should beappreciated that different features may be combined in different ways.In particular, not all the features shown above in a particularembodiment are necessary in every embodiment of the invention. Furthercombinations of the above features are also considered to be within thescope of some embodiments of the invention.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather the scope of the present invention isdefined only by the claims, which follow.

1. A programmable needle-less injection device, comprising: a nozzlecomprising a nozzle head with a fluid input hole and an injection hole,the nozzle head accepts a dose of a fluid from the fluid input hole tobe injected into skin of a patient through the injection hole, withoutpenetrating the skin with a needle; a fluid capsule that is connected tosaid nozzle head; wherein said fluid capsule provides the nozzle headwith multiple doses of fluid for successive injections, withoutreplacing the fluid capsule; an injection head for mounting said fluidcapsule and said nozzle head onto it, comprising a first mechanismadapted to forcefully push the dose of a programmable amount of fluidfrom said fluid capsule to said nozzle head and a second mechanism forinjecting by a programmable pressure the dose from said nozzle head intothe skin of the patient in at least one of a programmable velocity orthe programmable pressure applied to a surface of the skin of thepatient, wherein said nozzle head and said fluid capsule beingindependent from said injection head and being disposable; and whereinthe disposable nozzle head includes a plunger that seals between thenozzle head and the second mechanism; and wherein the plunger is adaptedto be moved up and down by the second mechanism to enable reception ofmultiple doses of fluid into the nozzle head and to inject them throughthe injection hole by the plunger.
 2. The programmable injection deviceaccording to claim 1, wherein the programmable injection device isprogrammable for a depth of penetration of the fluid into the skin ofthe patient.
 3. The programmable injection device according to claim 1,wherein the programmable pressure is controlled to determine a depth ofpenetration of the fluid into the skin of the patient.
 4. Theprogrammable injection device according to claim 1, wherein theprogrammable pressure is programmable in a range between 100 Atm and 200Atm.
 5. The programmable injection device according to claim 1, whereinthe programmable pressure is programmable initially in a range between100 Atm and 150 Atm.
 6. The programmable injection device according toclaim 1, wherein the programmable pressure is 120 Atm.
 7. Theprogrammable injection device according to claim 1, wherein theprogrammable pressure is 150 Atm.
 8. The programmable injection deviceaccording to claim 1, wherein the programmable pressure is applied for aprogrammable time interval.
 9. The programmable injection deviceaccording to claim 1, wherein the programmable pressure is applied in aprogrammable impulse shape.
 10. The programmable injection deviceaccording to claim 1, wherein the programmable pressure is applied by aspring.
 11. The programmable injection device according to claim 1,wherein a temperature of the fluid is programmable.
 12. The programmableinjection device according to claim 1, wherein the injection hole has adiameter of less than 0.5 mm.
 13. The programmable injection deviceaccording to claim 1, wherein the injection hole has a diameter between0.1 mm to 0.3 mm.
 14. The programmable injection device according toclaim 1, wherein the injection hole has a diameter that is determined byviscosity of the fluid.
 15. The programmable injection device accordingto claim 1, wherein p between the injection hole and the skin of thepatient is either more or less than 20 mm.
 16. The programmableinjection device according to claim 1, wherein a distance between theinjection hole and the skin of the patient is between 1 mm to 20 mm. 17.The programmable injection device according to claim 1, furthercomprising a tube connecting between the fluid capsule and the nozzle.18. The programmable injection device according to claim 17, wherein thetube is disposable.
 19. The programmable injection device according toclaim 1, wherein the fluid comprises at least one of collagen,hyaluronic acid, fat, silicon, water, PolymethylmethacrylateMicrospheres, Calcium Hydroxy Apatite Microspheres, Polyvinyl Alcohol orPolyethylene Glycol.